Field Of Biobanking Research Articles

An overview of Synlab SDN Biobank’s quality control system

Biobanks are valuable service units that ensure the usage of high-quality biological samples. They contribute to translational research, and their support may improve future therapeutic approaches. They store biological samples that can be used to examine circulation biomarkers, immune cells, and immunohistochemistry aspects of illnesses and further in-depth examinations using NGS techniques. The IRCCS Synlab SDN Biobank has about 70,000 well-preserved cryopreserved human samples from various diseases, primarily oncological but also neurological and cardiovascular. These biospecimens were taken from 25,000 participants underwent imaging with a contrast agent. The goal is to propose quality control assays that meet the requirements of the international standard ISO 9001:2015 and ISO 20387:2020 accreditation. PBMCs viability was determined, and immune subset cells were analyzed by flow cytometry. Furthermore, the expression of ubiquitous miRNAs was used to assess plasma sample integrity. The quality controls demonstrated that the biological samples were correctly cryopreserved; the preservation of human biological samples did not affect the quality of the biological samples tested. Indeed, the cryopreserved PBMCs had a vitality of more than 80%, and the lymphocyte subsets could be selected for future immune cell investigations. Furthermore, miRNA expression was highest in thawed plasma samples compared to the positive and negative controls. We evaluated the quality of our randomly selected biobank-thawed human samples. Both PBMCs and plasma samples fulfill the high-quality standards needed for biomedical research, assuring their long-term preservation. However, further research is needed in the biobanking field to establish globally accepted procedures to confirm the quality of biological samples.

Biobanks as a way to conserve biodiversity in the context of the continuing decline in the species diversity of wild flora and fauna

To date, human actions have significantly changed 75% of the Earth's surface. This has resulted in an unprecedented increase in the rate of biodiversity loss in human history. According to the International Union for Conservation of Nature and Natural Resources, over the past 500 years, as a result of direct or indirect influence of the anthropogenic factor, 774 animal species and 123 plant species have become extinct. To prevent further loss of biodiversity, in the context of the ongoing «crisis of biodiversity», all over the world, including Kazakhstan, there is a need for reliable conservation of the available genetic resources of plants and animals, primarily rare and endangered species. In this regard, specialized biobanks of organized collections of living biomaterials are successfully used worldwide for the conservation and restoration of populations of rare and endangered species of flora and fauna. The article presents information about some of the largest biobanks and their importance in solving this global problem. The experience of scientific centers of Kazakhstan in the field of biobanking of biomaterials of wild flora and fauna, including rare and endangered species, is given, and the results of the National Center for Biotechnology in this area are summarized.

Intellectual property rights in the context of biology, medicine and pharmacy: a look into the future

The article covers the study of some aspects of protecting the intellectual property rights in the areas of biology, medicine and pharmacy including biotechnological inventions. The rapid progress of science and technology, the generation and accumulation of knowledge, the possibilities to process large amounts of various data further stimulate the development of all social areas and unprecedentedly contribute to the emergence of innovations, in particular in the area of biotechnology. Intellectual property rights have a direct impact on the progress of medical and biological research, but increasingly require coordination with the ethical and moral principles of the society regarding the patentability of inventions in biology, medicine and pharmacy.The article analyzes the modern trends in the protection of intellectual property rights to biotechnology inventions at an international level, and forecasts the likely subsequent development in legal protection of intellectual property rights in the areas of biology, medicine and pharmacy in view of the ever increasing ethical and law controversies of medical and biological research in some areas, the emergence of big data, use of artificial intelligence, etc.The national legislation refers to the term «biotechnology» in the Law of Ukraine «On Environmental Protection», while not giving any legal definition of “biotechnology” in any laws. The Ukrainian intellectual property and health care legislation require reformation to get properly updated to respond to the ongoing challenges. There is a whole layer of gaps regarding the legal regulation of using biotechnology in Ukraine, and this extends to all areas where biotechnology is actually integrated. The use of biotechnology in biology, medicine and pharmacy requires a systemic and multi-aspect study in order to develop the appropriate legal norms.To ensure the stability of the pharmaceutical market, which is focused on the national manufacturer, it is necessary to create the proper conditions for the development of a high-tech research environment in Ukraine. It is necessary to improve nationallegislation in the field of biobanking and the legal regime of human biological material for the purpose of using it in research.

Prospects for biobanking in reproductive health: genetic aspects

Currently, one of the most promising areas of medicine is the development and implementation of new biomedical technologies in the field of human reproduction with the involvement of resources of biobanks and biocollections as well as modern genetic technologies. In this review, we considered the key dimensions of personalized medicine, such as biobanking and genomic medicine. We illustrated crucial aspects in the organization of human bioresource collections and the difficulties arising in the interaction of specialists in the field of biobanking. Problems in obtaining informed consent and collecting personal data are described. Furthermore, the need for creating and developing complex information systems for storing, processing, and analyzing data, creating genetic databases is emphasized. Foreign experience in consolidation of biobank data and the results of genomic studies is summarized. We also describe D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology’s experience in creating collections of human biomaterials (today it contains more than 60,000 samples, including samples of blood and its derivatives (plasma, serum, whole blood), urine samples, placental tissue, cell cultures, DNA, RNA, and others) and in quality management. The main results of genetic research are provided. Experience in these studies served as the basis for the creation of Biobank “Genofond” and the unique scientific facility “Human Reproductive Health”. The principle of creation of the collection, its purpose, and objectives for future research in the genetics of reproduction are described.

Decarbonization in Biobanking: A Potential New Scientific Area.

Calls to reduce or entirely remove the carbon footprint of ongoing activities, collectively termed as decarbonization, have become increasingly more vocal in health care with a number of recent, high profile consensus statements. These calls encourage the biobanking field, as one of the foundational health care research infrastructures, to consider decarbonization as a potential novel research area both in terms of the molecules and the equipment used in research. The current article provides a summary of the roundtable discussion during the 2022 ISBER Annual Meeting and Exhibits, highlighting the current knowledge gaps, challenges, and opportunities in this field. In particular, technological innovation, a greater awareness of the current situation, and behavioral change are important pieces of the puzzle to improving the future of decarbonization in biobanking, even if the eventually implemented routes between resource-abundant and resource-restricted settings might be distinctly different. This article sets the foundation for raising awareness of the subject and of subsequent steps that need to be undertaken.

Brief Reports Prepared by Students and Graduates of Master of Science in Biobanking.

Brief Reports Prepared by Students and Graduates of Master of Science in Biobanking.

Review of Indicators in the Context of Biobanking.

Background: Biobanks that intend to serve as high-performing and stable elements of an innovative research ecosystem must have an established system for regular measurement and evaluation using appropriately set indicators. The main objective of this study was to provide a comprehensive overview of indicators in the context of biobanking, with new perspectives to highlight the existence of numerous options and introduce indicators that could help overcome problems associated with the difficult assessment of the impact of biobanks. Methods: A literature review was performed to identify publications relevant to the topic of indicators in biobanking. The Web of Science Core Collection and PubMed databases were searched using specific keywords. In addition, three articles that focused on indicators designed for the evaluation of research infrastructures were included in the review. Results: Based on the scientific literature for the biobanking field, many types of quantitative and qualitative indicators exist. They are mainly related to the quantity and quality of data and samples, their distribution, the monitoring of research projects, and subsequent publication outputs. The indicators identified in the biobanking literature primarily focus on the outcome, not the impact. Conclusions: Indicators identified in the biobanking literature may be further expanded with suggestions designed for other types of research infrastructures, while considering the context where biobanks operate and the needs of individual biobanking stakeholders. The establishment of a comprehensive monitoring system that captures all necessary elements is crucial for modern biobanks.

A Survey on the Role of Artificial Intelligence in Biobanking Studies: A Systematic Review.

Introduction: In biobanks, participants’ biological samples are stored for future research. The application of artificial intelligence (AI) involves the analysis of data and the prediction of any pathological outcomes. In AI, models are used to diagnose diseases as well as classify and predict disease risks. Our research analyzed AI’s role in the development of biobanks in the healthcare industry, systematically. Methods: The literature search was conducted using three digital reference databases, namely PubMed, CINAHL, and WoS. Guidelines for preferred reporting elements for systematic reviews and meta-analyses (PRISMA)-2020 in conducting the systematic review were followed. The search terms included “biobanks”, “AI”, “machine learning”, and “deep learning”, as well as combinations such as “biobanks with AI”, “deep learning in the biobanking field”, and “recent advances in biobanking”. Only English-language papers were included in the study, and to assess the quality of selected works, the Newcastle–Ottawa scale (NOS) was used. The good quality range (NOS ≥ 7) is only considered for further review. Results: A literature analysis of the above entries resulted in 239 studies. Based on their relevance to the study’s goal, research characteristics, and NOS criteria, we included 18 articles for reviewing. In the last decade, biobanks and artificial intelligence have had a relatively large impact on the medical system. Interestingly, UK biobanks account for the highest percentage of high-quality works, followed by Qatar, South Korea, Singapore, Japan, and Denmark. Conclusions: Translational bioinformatics probably represent a future leader in precision medicine. AI and machine learning applications to biobanking research may contribute to the development of biobanks for the utility of health services and citizens.

Genomic Research in Reproduction and Biobanking: An Analysis of International Legal Approaches

The article examines the regulatory issues of genomic research in human reproduction and biobanking. The approaches to legal regulation at the level of international law, integration organizations, and individual states are analyzed. Based on the analysis, proposals for legal regulation are formulated. Regarding the legal regulation of genomic research in the field of biobanking, the article discusses the issue of the legal standing of biobanks, approaches to the legal regulation of biobanks in various countries, and formulates proposals for the commercial use of the results of genomic research in biobanking. The article also provides an overview of some judicial decisions that had a certain impact on forming legal regulation of genomic research in the field of biobanking and human reproduction.

Creation of a Forensic Pathology Biobank in Switzerland: which issues and research opportunities?

A biobank is a collection of biological material associated with health database. The field of biobanking has significantly developed over the past 30years. Research based on biobank material gives access to data of a large number of people and can often significantly accelerate the understanding of disease and improve the quality of care. In the University Center of Legal Medicine Lausanne-Geneva, samples collected during autopsies are used for forensic investigations. The legal and ethical framework to use these samples for research is often complex and confused, which is unfortunate given the potential of these biospecimens. Indeed, forensic samples are valuable for research because they originate in part from young (including pediatrics cases) and healthy people who are poorly represented in worldwide institutional biobanks. In this context at the beginning of the year 2019, the Forensic Pathology Biobank was created. Creation of a forensic pathology biobank is the best way to standardize local conservation practices and improve personal data management, thus providing a very valuable biological material for scientific projects. Its development gives rise to many questions about technical standards, ethical and legal issues but also many research opportunities.

Preparation of the “Lexique” for ISBER Best Practices 4th Edition for Biobankers in Indo-Pacific Rim Region

Statement of the Problem: Several standards and guidelines for biobanks or biorepositories have been published by various parties (e.g., the International Society for Biological and Environmental Repositore [ISBER] and the International Organization for Standardization [ISO]). These documents are invaluable for improving the routine practices of the biobanks but the implementation has proven to be challenging for those biobanks from the non-English regions because these resources are mostly written in English. Proposed Solution: The World Health Organization (WHO) has recently published the International Classification of Diseases 11th Revision (ICD-11) along with a translation tool (lexique) for potential users. This has inspired us to make a similar contribution in the biobanking field. All the regional ambassadors (RAs) and director-at-large (DAL) in the Indo-Pacific Rim (IPR) region worked together to produce a similar lexique for potential users of ISBER's Best Practices (BPs) 4th edition. A lexique with languages of Hindi, Indonesian, Vietnamese, and Japanese has been prepared. Conclusions: This lexique is a comparison table between various languages and is expandable to other languages. In addition, this lexique will be a good tool for understanding the ISBER BPs 4th edition.

Rise of Biobanking in the EU: Evidence from the Framework Programmes

he topic of biobanking has been anchoring in the world and Europe as well. The biobanking field today is characterised by heterogeneous entities that could be classified according to many different categories. This article aims to outline the process of the gradual embedding of the field of biobanking in the European Union (EU) from the point of view of the number of high-quality international research projects related to biobanking or biobanks as such. To identify these research projects, data from the European Commission's (EC's) database on research and innovation projects financed from Framework Programmes (FPs) of the European Union and the Horizon programme were used. It was found that the number of research and innovation projects in which biobanks played an important role more than doubled between 1994 and 2021. The highest increase in the number of biobank-related research and innovation projects occurred between 2002 – 2006 and 2007 – 2013. Several leading countries, in terms of the number of biobank related research projects, emerged during the whole period. The main actors were all countries of western Europe, characterised mostly by above-average performance in indicators such as GDP per capita, Human Development Index (HDI) or Euro Health Consumer Index (EHCI).

Russia State Policy in the Field of Biobanking: Present and Future

Russia State Policy in the Field of Biobanking: Present and Future

Biobanks and Individual Health Related Findings: from an Obstacle to an Incentive

Despite the benefits biobanks are expected to bring, there have recently been concerns raised that the public and private non-profit biobanks still prevailing in Europe often fail to reach their initial objectives due to a variety of reasons, including a shortage of funding and insufficient utilization of collections. The necessity to find new ways to manage biobanks has been clearly recognized and one way to do this is to follow the success of some commercial direct-to-consumer genetic testing (DTC GT) companies in the biobanking field. This paper is focused on a double role the return of individual health related findings (IHRF) detected through the biobanking activities can play in the management of biobanks. These findings can be seen as an untapped opportunity to offer health related information to biobank participants. At the same time, the IHRF policy can also serve as an additional tool that can improve biobanking governance. This paper aims to consider diverse IHRF approaches as well as to explore some key ethical concerns related to them. In particular, it reveals how different accounts of personal autonomy shape consent policies related to IHRF and emphasizes ethical controversies related to the commercial DTC GT initiatives as well as some non-profit biobanks.

Biosafety and biobanking: Current understanding and knowledge gaps

Infectious disease outbreaks, such as 'Coronavirus disease 2019′ (COVID-19), can constitute major global health threats with far-reaching consequences. As outbreaks develop, the international scientific community must provide high-quality scientific research-ready biological samples to solve the existing clinical and epidemiological questions to better combat the pandemic. Such examples are provided by dedicated biobank facilities, the latter collecting increasingly high volumes of biological samples. However, the more significant concentrations of infectious or potentially infectious biological materials can create a safety risk. The current short report describes the first attempt to identify the published scientific works on biobanking and safety. Three broad thematic areas have been identified: the physical security relevant to staff and sample integrity, the data safety aspects, and the governance parameters relating to the previous two. While the current publications reflect a broad alignment with existing standards and best practices in the biobanking field, they also demonstrate an opportunity for further in-depth work on this field in the post-COVID-19 era.

Letter to the editor: ISBER Two Decades and Beyond: Honoring Our Past, Celebrating the Present, and Envisioning Our Future.

Biopreservation and BiobankingVol. 19, No. 4 Review ArticlesFree AccessLetter to the editor: ISBER Two Decades and Beyond: Honoring Our Past, Celebrating the Present, and Envisioning Our FutureDebra Leiolani Garcia and Zisis KozlakidisDebra Leiolani GarciaAddress correspondence to:, Debra Leiolani Garcia, MPA, San Mateo, CA 94401, USA E-mail Address: dleiolani@gmail.comPrivate Consultant, San Mateo, California, USA.ISBER President (2019–2020).Search for more papers by this author and Zisis KozlakidisInternational Agency for Research on Cancer, World Health Organization, Lyon, France.ISBER President (2017–2018).Search for more papers by this authorPublished Online:13 Aug 2021https://doi.org/10.1089/bio.2021.29088.dlgAboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail As the International Society of Biological and Environmental Repositories (ISBER) celebrated its 20th anniversary, it was essential for its members to look back and reflect on how the society started and continues to grow as a global resource and collective force in the biobanking arena. ISBER strives to connect biobanks and related fields around the world to ensure quality through standardization and harmonization of biobanking practices. We have witnessed during the past 20 years that biobanking is being recognized as an indispensable research infrastructure activity underpinning scientific breakthroughs.As we reviewed our history, it became apparent that ISBER should capture the valuable work of its membership and the global biobanking community in an e-book highlighting its history and achievements (www.isber.org/resource/resmgr/20annibook/20thAnniversaryBook-ISBER-v0.pdf).The first edition of the e-book was initiated at the celebration of the 20th anniversary of the society and provides the inspiration for many more years to come. It articulates the distilled efforts and history of ISBER over the past two decades, the different individuals who have shaped the society into its current form, as well as the many efforts to investigate the diverse aspects ISBER as an active inclusive society, run by its members and responding to the evolving needs of the biobanking field as a whole.The history of ISBER is proof of how an important idea, such as the development of a society focused on the quality of biological research materials and biobanking, can come to realization, be expressed by a scientific journal,1 and eventually mature when there is committed leadership supported by interested, experienced, and enthusiastic members, all aided by a dedicated administrative staff. ISBER was created to be an international forum, creating opportunities for networking, education, and innovation by providing harmonized approaches to emerging challenges in repositories, as well as fostering ideas to create new solutions. Today, continuing on those footsteps, the primary goals of the society include creating educational and training opportunities; providing a forum for dissemination of state-of-the-art policies, processes, and research findings; and showcasing innovative technologies, products, and services.Two decades is a very short period of time for a global concept to become established and flourish, such that it is now considered an infrastructural component vital to delivering modern precision research. This sustained growth of biobanking and its eventual acceptance as a discipline form part of ISBER's legacy. Since 1999, academia, biobankers, patient advocates, industry and state representatives, lawyers, and others with an interest in biobanking have met at least once per year during the ISBER annual meeting to share and expand their expert knowledge in the field. This global focal point of ISBER meetings has created a strong foundation for the regular exchange of experiences, networking opportunities, as well as the development of best practices educational tools with a global reach, especially as the biobanking field develops in Asia, Eastern Europe, Africa, and South America.2ISBER is proud of its many accomplishments over the past 20 years. It will continue to move forward with strong, visionary, and thought-provoking leadership, along with its supportive management. The society will continue its onward stride into its third decade as the premier global forum that addresses the harmonization of scientific, technical, legal, and ethical issues relevant to repositories of biological and environmental specimens.DisclaimerWhere authors are identified as personnel of the International Agency for Research on Cancer/WHO, the authors alone are responsible for the views expressed in this article and they do not necessarily represent the decisions, policy, or views of the International Agency for Research on Cancer/WHO.

Education for future biobankers - The state-of-the-art and outlook

Biobanking as a quickly growing branch of personalised medicine has undergone enormous progress during last two decades. Nowadays it is a well developed and structured multidisciplinary field that reflects developments and advances of biomedical research based on principles of predictive, preventive and personalised medicine (PPPM/3PM). All these trends in PPPM progress have to be translated into practice and education of new generation of scientists and healthcare givers. The importance of biobanks for multitasking research, personalised treatment, and health care systems was emphasised by many scientists and health care experts. As biobanking carries multidisciplinary character currently including more professionals than ten—twenty years ago, new generation of professional biobankers is urgently needed. To create new generation of biobankers who are fully competent to answer more and more scientific and practical questions, new study programmes, novel university curricula, and topic-dedicated courses are essential. The aim of the review is to present basic forms, trends of biobanking education offered by various biobanking related bodies and to highlight future needs. The first step is to cover all activities and duties of biobanks: acquiring, collecting, storageing and sharing biological samples and associated data, using adequate assessment for both - materials and data, taking into consideration ethical, legal, and societal issues (ELSI), responding to all stakeholder needs including pharmaceutical and other related industries, patient organisations and many other interested groups, emerging technologies and innovations as well as current and future requirements of health care systems. To compile educational programmes is a comprehensive task for all actors involved in the field of biobanking who contribute to the harmonised process of creating high educational level for future generation of biobankers. The exchange of experience involving extensive international collaboration is the way how to facilitate the process of creating optimal biobanking education.

National Association of Biobanks and Biobanking Specialists: New Community for Promoting Biobanking Ideas and Projects in Russia.

The research biobanking field is developing rapidly in Russia. Over the course of the last decade, numerous biobanks were created or formed from existing collections of human and environmental biospecimens. The Russian National Association of Biobanks and Biobanking Specialists (NASBIO) was established in December 2018, aiming to: (1) unite professionals and research centers to create and develop a network of biobanks in Russia; (2) provide services and expertise in the field of biobanking; (3) execute various research projects utilizing biobanks' infrastructure; and (4) facilitate integration of Russian biomedical research centers into global research activities. The organizational structure, aims, and plans of this newly formed national association are reviewed in this article. The founders of NASBIO hope that the association will promote further development of biobanks and their networking in Russia, which is critically important for the success of national biomedical, pharmaceutical, and biotechnological research, and can facilitate international biobanking projects on a global scale.

Public awareness of and attitudes towards research biobanks in Latvia.

BackgroundPublic awareness and engagement are among the main prerequisites for protecting the rights of research participants and for successful and sustainable functioning of research biobanks. The aim of our study was to analyse public awareness and attitudes towards research biobanks in Latvia, and to compare these data with the results of the 2010 Eurobarometer study. We also analysed the influence of awareness and attitudes towards biobanks on willingness to participate in biobank studies and on preferred type of informed consent.MethodsWe developed a 12-question survey repeating seven questions about biobanks from the 2010 Eurobarometer questionnaire and adding five others. After describing the study variables, we performed a two-stage analysis of the results. In the first stage we analysed differences between the answers from 2010 and 2019 and conducted univariate analyses of relationships among particular variables, and between those variables and the socio-demographic characteristics of participants. In the second stage we investigated multivariable associations of willingness to participate and type of consent with awareness, trust and the socio-economic characteristics of participants.ResultsAccording to our study, the general public in Latvia is still not well informed about research biobanks. Fewer respondents have heard about research biobanks than in 2010. At the same time, the number of respondents who are willing to donate biological samples and personal data to a biobank has increased, e.g. the number of respondents who would definitely or probably be willing to provide information about themselves has increased from 25.8.% to 40.7 since 2010. Overall, concerns about the donation of different types of biological samples and data to a biobank have slightly decreased.ConclusionsPublic awareness about biobanks is important for their sustainability. It needs to be increased not only by traditional methods of informing the public, but also by more innovative and participatory approaches, e.g. by citizen science projects. There is a need to strengthen the public visibility and trustworthiness of ethics committees in Latvia in the field of biobanking.

The Significance of Biobanking in the Sustainability of Biomedical Research: A Review.

Biobank, defined as a functional unit for facilitating and improving research by storing biospecimen and their accompanying data, is a key resource for advancement in life science. The history of biobanking goes back to the time of archiving pathology samples. Nowadays, biobanks have considerably improved and are classified into two categories: diseased-oriented and population-based biobanks. UK biobank as a population-based biobank with about half a million samples, Biobank Graz as one of the largest biobanks in terms of sample size, and IARC biobank as a specialized WHO cancer agency are few examples of successful biobanks worldwide. The present review provides a history of biobanking, and after presenting different biobanks, we discuss in detail the challenges in the field of biobanking and its future, as well. In the end, ICR biobank, as the first cancer biobank in Iran established in 1998, is thoroughly described.